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The Disposable Dual Action Tissue Clip is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.

The Disposable Dual Action Tissue Clip is indicated for clip placement within the gastrointestinal tract for the purpose of:

Endoscopic marking,

Hemostasis for

·Mucosal/sub-mucosal defects

The proposed device Disposable Dual Action Tissue Clip is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 1 year.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the requested details, because the provided text is a 510(k) summary for a medical device (Disposable Dual Action Tissue Clip) and does not contain detailed information about specific acceptance criteria or a dedicated study report with performance data.

The document states that "Performance testing was conducted to demonstrate the essential performance of the proposed device... and confirmed that the proposed device works as intended with the compatible devices." It then lists various bench tests performed (Dimension, Release Force, Clamping Strength, Tensile Strength, etc.) and mentions that these were "tested and evaluated as substantially equivalent to the predicate device."

However, it does not provide:

• A table of specific acceptance criteria (e.g., "Clamping Strength must be > X N") and corresponding reported device performance values.
• Sample sizes for test sets (beyond implying "bench tests").
• Data provenance for any performance data.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies, as it explicitly states "No animal study is included in this submission" and "No clinical study is included in this submission."
• Details about the training set or its ground truth, as this is a mechanical device subject to bench testing, not an AI/ML algorithm.

Therefore, I cannot fulfill your request for the specific comparative performance data, sample sizes, and expert details as they are not present in the provided FDA 510(k) summary.

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